- Small Pharma (DMT) has received approval from the U.K. Medicines and Healthcare products Regulatory Authority (MHRA) to initiate a drug interaction clinical trial
- The study will assess the interaction between serotonin reuptake inhibitors (SSRIs) and SPL026, the company’s lead N, N-dimethyltryptamine (DMT) candidate, in patients with major depressive disorder
- It will assess the impact of SSRIs on the safety, tolerability, and effects of SPL026 with psychotherapy in up to 24 patients
- Small Pharma Inc. (DMT) is up 4.00 per cent trading at $0.13 per share as of 1:30 pm ET
Small Pharma (DMT) has received approval to initiate a drug interaction clinical trial in the U.K.
The study, approved by the U.K. Medicines and Healthcare products Regulatory Authority (MHRA), will assess the interaction between serotonin reuptake inhibitors (SSRIs) and SPL026, the company’s lead N, N-dimethyltryptamine (DMT) candidate, in patients with major depressive disorder.
Conducted at two clinical research sites, the study will assess the impact of SSRIs on the safety, tolerability, and effects of SPL026 with psychotherapy in up to 24 patients.
The company’s Chief Medical and Scientific Officer, Dr. Carol Routledge said that in the Phase I/IIa SPL026 clinical trial that is underway, patients must be withdrawn from existing antidepressant medication, which can be disruptive and unsettling for some. She admits that this may not always be in the best interest of patients, even if the medication is ineffective.
“Encouraging results from this study could facilitate patient recruitment in future clinical trials as patients may no longer be required to discontinue their SSRI medication. In the longer term, successful results could open up the potential to broaden patient accessibility to DMT-assisted psychotherapy.”
Chief Executive Officer, George Tziras added that the company values patient access and that is how it approaches its research and development.
“As we progress through our clinical programs, it’s key that we are agile and most importantly patient-led.”
The trial is expected to begin in Q3 2022, with dosing completion anticipated in the first half of next year.
DMT is a naturally occurring psychedelic substance found in plants and in the brain of mammals. There is scientific evidence that suggests it has potential rapid-acting and long-lasting antidepressant effects.
Small Pharma is a neuroscience biotechnology company specialized in discovering and developing novel treatments for mental health conditions, with a focus on depression.
Small Pharma Inc. (DMT) is up 4.00 per cent trading at $0.13 per share as of 1:30 pm ET.